Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06018558 | Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy | PHASE1 | ACTIVE NOT_RECRUITING | 60 | — | — | Feb 23, 2023 | May 29, 2026 | Dec 5, 2025 | 12 | United States |
The primary endpoint is safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
We will use Slit-lamp Biomicroscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
We will use Indirect ophthalmoscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Measured by letter score. A higher score represents better vision
Measured by applanation or rebound tonometry with confirmation with Goldmann tonometer if IOP is outside normal range (8-21mmHg).
| Arm | Type | Description |
|---|---|---|
| Phase1 Dose Escalation- Low Dose (2.5×10E10 vg/mL): | EXPERIMENTAL | Low Dose (2.5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the low dose concentration. |
| Phase1 Dose Escalation- Medium Dose (5×10E10 vg/mL): | EXPERIMENTAL | Medium Dose (5×10E10 vg/mL): Subjects will receive a subretinal injection of OCU410 in the medium dose concentration. |
| Phase1 Dose Escalation- High Dose (1.5×10E11 vg/mL): | EXPERIMENTAL | High Dose (1.5×10E11 vg/mL): Subjects will receive a subretinal injection in the high dose concentration. |
| Phase 2 Dose Expansion: Maximum tolerated dose (MTD) from Phase 1-Randomized Arm | EXPERIMENTAL | Maximum tolerated dose (MTD) from Phase 1: Subjects will receive a subretinal injection in the MTD concentration. |
| Phase 2 Dose Expansion: Lower Dose from Phase 1-Randomized Arm | EXPERIMENTAL | Subjects will receive a subretinal injection of OCU410 in a Lower Dose concentration. |
| Control Arm | NO_INTERVENTION | No Intervention Control Arm: Subject will not receive any active study intervention |
| Name | Type | Description |
|---|---|---|
| OCU410 | GENETIC | Subretinal administration of OCU410 |
Inclusion Criteria: 1. Subjects 50 years of age or older. 2. BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent). 3. Fundus autofluorescence (FAF) imaging shows: 1. Total GA area ≥2.0 and ≤20.5 mm2 (1 and 8 disk are...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | — | Pegcetacoplan |